Impax Laboratories, Inc. (IPXL), along with TOLMAR, Inc., announced Wednesday that the U.S. Food and Drug Administration or FDA has granted final approval for the generic version of Solaraze Gel (diclofenac sodium-3%).

TOLMAR was the first company to file a substantially complete Abbreviated New Drug Application or ANDA for the generic version of Solaraze Gel containing a Paragraph IV certification.

Impax said its generics division, Global Pharmaceuticals, intends to commercialize this first-to-file product shortly. The last Orange Book listed patent expires August 11, 2015.

Under the Development, Supply and Distribution Agreement with TOLMAR entered in 2012 June, Impax was granted an exclusive license to commercialize generic Solaraze in the United States and its territories. Under the terms of that deal, TOLMAR is responsible for developing and manufacturing the product, and Impax is responsible for the marketing and sale of the product.

According to IMS Health, U.S. sales of Solaraze Gel 3% were approximately $78 million for the 12 months ended September 2013.

Solaraze is from PharmaDerm, a Division of Fougera Pharmaceuticals Inc.

American Express Co. said that beginning in April 2018, card members will not be required to sign receipts for their credit card purchases. The company thus joins other major card companies such as Mastercard Inc. and Discover Financial Services Inc., who have previously announced similar changes.

Costco members can now enjoy MoviePass subscription service and Fandor streaming service for $89.99. The subscription will be for one year.
The offer will be available on Costco website for up to December 18. The annual subscription will offer access to Fandor's library of more than 5000 films and...

A Houston woman has said that Spirit Airlines Inc. kicked her family off a flight Friday morning as she did not immediately stop breastfeeding her 2-year-old son. Mei Rui, a concert pianist and cancer researcher, said she was asked by flight attendants to stop breastfeeding her son and put him into his own seat for takeoff.